With a theme of “Sustaining the Momentum for Regulatory Harmonization in Africa”, the conference was a platform for stakeholders to brainstorm on the role of ethical and regulatory approval of clinical trials in bridging the gap between research and development given the existing vacuum in advancing clinical trials that are relevant for diseases affecting African countries.

Access to medicines remains a big challenge in the African continent. Among the factors that are attributable to this situation is the current medicines regulatory systems in Africa which tends to be as diverse in form and content as there are African countries.

Therefore the overall goal of the Conference was to review progress and deliberate on actions for sustaining the momentum for regulatory systems strengthening and harmonisation in Africa. Specifically, the conference was in place to review the progress on regulatory systems strengthening and harmonisation in Africa for improved access to medical products and health technologies.

Dr. Samvel Azatyan, from WHO said that: ‘’...There are several bottlenecks that hinder patients from getting access to medicines and technologies. One-third of the world’s populations still suffer access to medicines. There is the need for a prompt facilitation by individual countries to ensure that there are regulations to avoid proliferation of substandard and fake medicines into countries. This would require more funding as well as efficient skills and workforce...” He added that we must continue with the implementation of the African Medicine Regulatory Harmonization (AMRH) and also support the African Medicines Agency (AMA) with funding.

Mrs. Delese Mimi Darko, CEO of FDA-Ghana also added that, all the 55 countries forming 5 Regional Economic Communities (RECs) need to open up a little more to see how we can move the process of harmonization forward. New health technologies are emerging therefore, there is the need for collaborations towards a successful regulation.

It was highlighted that in order to sustain the momentum of the role of civil society in strengthening the regulatory systems in Africa, there needs to be early and an all-inclusive collaboration between the CSOs, regulators, donors, patients, payers and industry at all levels.

Civil society was also tasked with promoting public awareness and accountability from the regulatory system, whilst taking the AU model law downwards so that communities can understand and appreciate them, in addition to the numerous benefits the regulatory harmonization holds for patients in terms of access to medicines (real opportunities for patients to access and use high quality health services, innovative health technologies and products).

The conference offered the following opportunities;

For stakeholders to understand that, patients can no longer wait. In a quote, Luther Gwaza from WHO said that; ‘Medicines delayed by regulatory harmonization mechanisms is medicines denied.’

The need to develop a set of competency model for regulators.

The need to promote peaceful and inclusive societies for sustainable development, provide access to justice for all and build effective, accountable and inclusive institutions at all levels.

The need to move towards the implementation of the bioequivalence standards in approval for generics through the regional harmonization mechanisms.

The need to review progress and identify actions towards sustaining the momentum.

A few Challenges were also identified as follows:

The lack of strong partnerships and collaborations to address the complexities of the regulatory harmonization.

Lack of new diagnostics, tools and skills

The need for support through capacity building

On bridging the gap between patients and access to medicines in Africa,

IAPO is focusing on building the capacity of our members to reach out to patients’ organizations across the region and to develop a strong network that can advocate for a patient-centered AMA. For example, on 4th - 5th July 2017, 30 of IAPO’s member organizations and stakeholders, representing ten African countries, came together in Entebbe, Uganda, to attend the African Regional Meeting.

The meeting culminated in delegates making a united call for a patient-centered AMA, in which patients are meaningfully engaged. Delegates engaged in lively and fervent discussions around the ongoing AMRH initiative, exchanging views and perspectives on how African patients can be feasibly and meaningfully involved in the establishment and future development of the AMA, which is set to be launched by the end of 2018. Delegates of the meeting drafted a joint statement - 'the Entebbe Statement' - to build consensus in making this call. It should be underscored that it was apparent at this meeting that for the majority of our members, it was the first time that they were "hearing" about AMA. This was an opportunity for the community of IAPO's African members to come together and call for the establishment of a patient-centric African Medicines Agency.

As a global movement of patients, IAPO is accelerating efforts to empower patient advocates in Africa by linking them to patient advocates around the world in particular Europe where the European Medicines Agency (EMA) is already established. For instance, during the Entebbe Meeting, a presentation was made by François Houÿez from the European Organization for Rare Diseases (EURORDIS), who also represents EURORDIS at the Patients’ and Consumers’ Working Party (PCWP) at the EMA.

Following our African Regional Meeting, IAPO is committed to working with its African members towards a patient-centric AMA. At the same time, we are continuing contributing our input within EMA’s Framework for interaction with patient and consumers organizations (the Framework) and the Patients and Consumers Working Party (PCWP), of which IAPO is part, and playing an active role in the various EMA’s patient engagement initiatives. Our long-term objective is to make sure that patients are at the center of the harmonization processes unfolding in the various world regions. This is the primary way through which patients’ voice can be truly integrated in decision-making mechanisms, processes, and outputs.

Key messages that patient advocates can draw on to emphasize the value of structured patient engagement in harmonization mechanisms and processes:

Patient engagement in regulatory harmonization must take place as early as possible and be nurtured over time; “Leave no-one behind” means more than access to medicines;

Harmonizing does not mean ignoring differences;

IAPO is committed to keeping the momentum going by ensuring that patient’s views and perspectives become a necessary ingredient for a proper development of both on-going and newly launched harmonization processes.